JP6618099B2 - 安定性に優れた固形製剤 - Google Patents

安定性に優れた固形製剤 Download PDF

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JP6618099B2
JP6618099B2 JP2019120378A JP2019120378A JP6618099B2 JP 6618099 B2 JP6618099 B2 JP 6618099B2 JP 2019120378 A JP2019120378 A JP 2019120378A JP 2019120378 A JP2019120378 A JP 2019120378A JP 6618099 B2 JP6618099 B2 JP 6618099B2
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preparation
formula
compound represented
acid
solid preparation
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JP2019189635A (ja
Inventor
直也 水谷
直也 水谷
甫享 森本
甫享 森本
真希 山下
真希 山下
正晃 伊藤
正晃 伊藤
木村　豪
豪 木村
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Shionogi and Co Ltd
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Shionogi and Co Ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/5375—1,4-Oxazines, e.g. morpholine
    • A61K31/5383—1,4-Oxazines, e.g. morpholine ortho- or peri-condensed with heterocyclic ring systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1611—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • A61P31/16—Antivirals for RNA viruses for influenza or rhinoviruses

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Virology (AREA)
  • Inorganic Chemistry (AREA)
  • Biophysics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pulmonology (AREA)
  • Biochemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
JP2019120378A 2018-04-24 2019-06-27 安定性に優れた固形製剤 Active JP6618099B2 (ja)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2018083006 2018-04-24
JP2018083006 2018-04-24

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
JP2019523143A Division JP6590436B1 (ja) 2018-04-24 2019-04-23 安定性に優れた固形製剤

Publications (2)

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JP2019189635A JP2019189635A (ja) 2019-10-31
JP6618099B2 true JP6618099B2 (ja) 2019-12-11

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Country Link
US (1) US11925648B2 (zh)
JP (1) JP6618099B2 (zh)
KR (1) KR102501180B1 (zh)
CN (1) CN112236146A (zh)
AR (1) AR115354A1 (zh)
AU (1) AU2019259686B2 (zh)
BR (1) BR112020021059B1 (zh)
CA (1) CA3098006A1 (zh)
MX (1) MX2022009094A (zh)
TW (2) TWI788557B (zh)
WO (1) WO2019208540A1 (zh)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20230183205A1 (en) 2020-05-15 2023-06-15 Shionogi & Co., Ltd. Pharmaceutical composition in which production of impurities is suppressed
JP2022108727A (ja) * 2021-01-13 2022-07-26 日曹商事株式会社 フマル酸含有固形製剤
WO2024002054A1 (en) * 2022-06-27 2024-01-04 Taigen Biotechnology Co., Ltd. Pharmaceutical composition comprising a cap-dependent endonuclease inhibitor

Family Cites Families (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH09249563A (ja) * 1996-03-11 1997-09-22 Nippon Iyakuhin Kogyo Kk チザニジン含有組成物
FR2759293B1 (fr) * 1997-02-11 1999-04-30 Ethypharm Lab Prod Ethiques Microgranules contenant du cisplatine, procede de fabrication, preparation pharmaceutique et utilisation en polychimiotherapie ou en association avec une radiotherapie
BR9910494B1 (pt) * 1998-05-15 2011-11-01 composições sólidas contendo derivados de ácido gama-aminobutìrico e processo para o seu preparo.
DE19831869A1 (de) 1998-07-16 2000-01-20 Merck Patent Gmbh Farbgebung mit Perlglanzpigmenten im Lebensmittel- und Pharmabereich
JP5202856B2 (ja) * 2006-03-06 2013-06-05 富山化学工業株式会社 トシル酸トスフロキサシンを含有する粒状固形製剤
TW200808375A (en) * 2006-05-12 2008-02-16 Otsuka Pharma Co Ltd Hydrogel suspension and manufacturing process thereof
JP2008007420A (ja) 2006-06-27 2008-01-17 Mitsubishi Tanabe Pharma Corp 造粒物
KR100960318B1 (ko) * 2007-08-08 2010-06-04 주식회사 포스코 쌍롤식 박판주조장치의 에지댐 진동조정 장치
WO2009044854A1 (ja) * 2007-10-03 2009-04-09 Asahi Breweries, Ltd. 顆粒、錠剤およびそれらの製造方法
JP2010120912A (ja) 2008-11-21 2010-06-03 Lead Chemical Co Ltd ５−メチル−１−フェニル−２−（１ｈ）−ピリドン含有貼付剤
MX344189B (es) * 2010-03-31 2016-12-08 Supernus Pharmaceuticals Inc Formulaciones de mazindol.
IN2014CN02850A (zh) 2011-10-31 2015-07-03 Glaxosmithkline Intellectual Property Ltd
JP2016079102A (ja) 2014-10-10 2016-05-16 テバ製薬株式会社 ソリフェナシン含有製剤
MD3428170T2 (ro) * 2015-04-28 2021-06-30 Shionogi & Co Derivat de piridonă policiclică anti-gripal și promedicament al acestuia
SI3290424T1 (sl) * 2015-04-28 2023-03-31 Shionogi & Co., Ltd. Substituirani policiklični piridonski derivati in njihovo predzdravilo
CR20180356A (es) 2015-12-15 2018-08-22 Shionogi & Co Un medicamento caracterizado por combinar un inhibidor de la endonucleasa cap-dependiente del virus de la influenza y un fármaco anti-influenza
SG11201810655QA (en) 2016-06-20 2019-01-30 Shionogi & Co Method for producing substituted polycyclic pyridone derivative and crystal of same
KR20190014086A (ko) 2016-08-10 2019-02-11 시오노기세야쿠 가부시키가이샤 치환된 다환성 피리돈 유도체 및 그의 프로드러그를 함유하는 의약 조성물
AR113748A1 (es) 2017-10-06 2020-06-10 Shionogi & Co Proceso estereoselectivo para preparar derivados de piridona policíclicos sustituidos
TWI795462B (zh) * 2017-11-17 2023-03-11 日商鹽野義製藥股份有限公司 光安定性及溶出性優異的醫藥製劑
CN108440564B (zh) * 2018-04-11 2019-08-06 安帝康（无锡）生物科技有限公司 被取代的多环氨基甲酰基吡啶酮衍生物及其前药

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Publication number Publication date
AU2019259686B2 (en) 2023-05-25
TWI788557B (zh) 2023-01-01
JP2019189635A (ja) 2019-10-31
TW202000206A (zh) 2020-01-01
CA3098006A1 (en) 2019-10-31
WO2019208540A1 (ja) 2019-10-31
MX2022009094A (es) 2022-08-18
TW202313057A (zh) 2023-04-01
BR112020021059B1 (pt) 2022-08-30
US20210106589A1 (en) 2021-04-15
AR115354A1 (es) 2020-12-23
BR112020021059A2 (pt) 2021-02-17
KR102501180B1 (ko) 2023-02-21
KR20200144127A (ko) 2020-12-28
TWI822498B (zh) 2023-11-11
AU2019259686A1 (en) 2020-10-29
US11925648B2 (en) 2024-03-12
CN112236146A (zh) 2021-01-15

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